MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLM TUBING SET W/BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2020

Event Type  malfunction  

Event Description

The decision was made to change the circuit for concern over impending oxygenator failure, since the delta p's have been displaying a rapid rate of rise.No clots were visible after the circuit change, nor when the disposable was drained immediately following the circuit change.No negative outcome is known.(b)(4).

Manufacturer Narrative

The manufacturer requested the product in question for further investigation in the laboratory of the manufacturer on 2020-01-31.It was performed by the complaint lab on 2020-03-24.Results: during optical examination the hls oxygenator a yellowish discoloration in the housing can be detected, located by the blood outlet connector.This could be an indication that condensation has formed in the housing from the pressure sensor or liquid has leaked in and that the sensor did not function properly.No clots were rinsed during cleaning and rinsing the oxy with water.No leakage was detected in the leak test carried out in accordance with lv 201.After connection to a cardiohelp the error message "part sensor disconnected" appeared.Since the issue could be reproduced by complaint lab, the failure could be confirmed.The most probable root cause could be that liquid entered the pump housing and the sensors and this could lead to the problems with the pressures.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.

Event Description

Complaint number: (b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9734715
• MDR Text Key: 199984849
• Report Number: 8010762-2020-00072
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2021
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Device Lot Number: 70135251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other